Remote Associate Director, Bioanalysis & PK Leadership

Otsuka America Pharmaceutical Inc.; Concord (NH); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Prescription coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. seeks a scientifically driven Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities across clinical development, with emphasis on PK and biomarkers.

The role leads CRO collaborations, ensures audit-ready data, and drives method development, validation, and data integrity while exploring new analytical technologies to enhance trial execution and data quality.

Qualifications

• PhD with a minimum of 5 years in regulated bioanalysis or an MS/BS with 8+ years in the field.
• Demonstrated expertise in regulated bioanalysis for clinical development, incl. PK and biomarker assays.
• Strong knowledge of global bioanalytical regulatory guidance and industry standards.
• Hands-on experience with LC-MS/MS, ELISA, ECL, flow cytometry, and other relevant platforms.
• Experience with immunogenicity assays (ADA/NAb) is a plus.
• Experience managing CROs/external partnerships including budgets, timelines, and compliance.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting.
• Develop and maintain partnerships with bioanalytical CROs and vendors.
• Monitor vendor performance and ensure timelines, quality, and regulatory compliance.
• Ensure activities follow global regulatory guidance and industry best practices.
• Serve as SME on project teams, providing recommendations and risk assessments.
• Support regulatory submissions with document reviews and responses to inquiries.
• Identify and evaluate emerging analytical technologies for trial execution and data quality.
• Drive continuous improvement and champion new technologies within bioanalysis.

Skills

Pharmacokinetics

Biomarker assays

LC-MS/MS

ELISA/ECL

Flow cytometry

Immunogenicity assays

CRO management

Project management

Regulatory knowledge

Education

PhD in Bioanalytical Science

MS in related field

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. seeks a scientifically driven Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities across clinical development, with emphasis on PK and biomarkers.

The role leads CRO collaborations, ensures audit-ready data, and drives method development, validation, and data integrity while exploring new analytical technologies to enhance trial execution and data quality.